Combined Bleaching Technique: Efficacy and Tooth Sensitivity

NCT ID: NCT03089216

Last Updated: 2019-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-01
• Study Completion Date: 2018-12-31

Brief Summary

The aim of this clinical study is to evaluate the efficacy and dental sensitivity associated with Combined Bleaching Technique (in-office + at-home) varying in-office bleaching application under two different time protocols, and dentifrice containing arginine 8% and carbonate calcium use. One hundred eight participants who meet the study inclusion criteria will be selected. The desensitizing agent used will be a dentifrice containing 8% arginine and calcium carbonate. In each evaluation will be determined: tooth sensitivity and color. The data collected will be submitted to the factorial statistical analysis for evaluation of color and chi-square test for tooth sensitivity (α = 5%).

Detailed Description

This study will be conducted under the CONSORT recommendations. After approval by the Ethics Committee for Research duly registered, the trial will be conducted in the clinic of dental school at the Federal University of Goias located in Goiania. One hundred eight participants 108 volunteers will be selected on the criteria that qualify inclusion and exclusion from the study will be reported all volunteers were examined not qualify under the criteria for inclusion as part of the initial according to CONSORT recommendations .

After signing the signed an informed consent form all volunteer participants will receive a dental prophylaxis with pumice and water in a rubber cups for the removal of extrinsic stains two weeks before the beginning of tooth whitening.

Conditions

Tooth Bleaching; Tooth Sensitivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Combined Bleaching(2x20)

In-office: 35% hydrogen peroxide of 20 minutes each. At-home: 10% carbamide peroxide

Group Type: EXPERIMENTAL

Combined Bleaching(2x20)

Intervention Type: PROCEDURE

one clinical session with two applications of 35% hydrogen peroxide of 20 minutes each. 10% carbamide peroxide for two hours daily over the course of two weeks.

Combined Bleaching(2x20) with arginine

Combined Bleaching(2x20) with arginine In-office: 35% hydrogen peroxide of 20 minutes each. At-home: 10% carbamide peroxide Desensitizing agent: dentifrice containing 8% arginine and calcium carbonate.

Group Type: EXPERIMENTAL

Combined Bleaching(2x20) with arginine

Intervention Type: PROCEDURE

one clinical session with two applications of 35% hydrogen peroxide of 20 minutes each. 10% carbamide peroxide for two hours daily over the course of two weeks.

8% arginine and calcium carbonate

Intervention Type: DRUG

using during all the treatment.

Combined Bleaching(1x20)

In-office: 35% hydrogen peroxide of 20 minutes each. At-home: 10% carbamide peroxide

Group Type: EXPERIMENTAL

Combined Bleaching (1x20)

Intervention Type: PROCEDURE

one clinical session with one application of 35% hydrogen peroxide of 20 minutes each. 10% carbamide peroxide for two hours daily over the course of two weeks.

Combined Bleaching(1x20) with arginine

Combined Bleaching(1x20) with arginine In-office: 35% hydrogen peroxide of 20 minutes each. At-home: 10% carbamide peroxide Desensitizing agent: dentifrice containing 8% arginine and calcium carbonate.

Group Type: EXPERIMENTAL

Combined Bleaching(1x20) with arginine

Intervention Type: PROCEDURE

one clinical session with one application of 35% hydrogen peroxide of 20 minutes each. 10% carbamide peroxide for two hours daily over the course of two weeks.

8% arginine and calcium carbonate

Intervention Type: DRUG

using during all the treatment.

Interventions

Combined Bleaching(2x20)

one clinical session with two applications of 35% hydrogen peroxide of 20 minutes each. 10% carbamide peroxide for two hours daily over the course of two weeks.

Intervention Type: PROCEDURE

Combined Bleaching(2x20) with arginine

one clinical session with two applications of 35% hydrogen peroxide of 20 minutes each. 10% carbamide peroxide for two hours daily over the course of two weeks.

Intervention Type: PROCEDURE

Combined Bleaching (1x20)

one clinical session with one application of 35% hydrogen peroxide of 20 minutes each. 10% carbamide peroxide for two hours daily over the course of two weeks.

Intervention Type: PROCEDURE

Combined Bleaching(1x20) with arginine

one clinical session with one application of 35% hydrogen peroxide of 20 minutes each. 10% carbamide peroxide for two hours daily over the course of two weeks.

Intervention Type: PROCEDURE

8% arginine and calcium carbonate

using during all the treatment.

Intervention Type: DRUG

Other Intervention Names

dentifrice containing carbonate arginine

Eligibility Criteria

Inclusion Criteria

• Upper and lower anterior teeth without restorations;
• Upper and lower anterior teeth that have never undergone a bleaching procedure and are A2 or darker in color compared to the Vita Classical).

Exclusion Criteria

• Presence of primary and/or secondary carious lesion (s) on upper and lower anterior teeth;
• Presence of non-carious lesions, such as abfraction, erosion and abrasion;
• Presence of clinically visible cracks or defects of dental enamel on the dental surfaces of the upper and lower anterior teeth;
• Use of fixed orthodontic appliances;
• Presence of tooth sensitivity classified as equal to or greater than mild;
• Presence of severe dental dimming;
• Presence of parafunctional habits;
• Presence of any oral pathology;
• Smokers;
• pregnant and lactating women

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Terezinha de Jesus Esteves Barata

OTHER

Sponsor Role: lead

Responsible Party

Terezinha de Jesus Esteves Barata

tde Jesus Esteves Barata

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Isabella N Favarão, DDS, MS

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal de Goias

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

043178

Identifier Type: -

Identifier Source: org_study_id